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Infant Incubator
EUDAMEDClass IIb (EU MDR)
Ref OKM 801Ref OKM 801 555Ref OKM 862 555Model OKM 862Ref OKM 862 000Ref OKM 862 333Ref OKM 862 999Ref OKM 801 222Ref OKM 862 111Ref OKM 801 444Ref OKM 801 999
Identity
- Trade Name
- Infant Incubator EUDAMED
- Device Name
- Infant Incubator EUDAMED
- Model / Reference
- OKM 801 EUDAMEDOKM 801 555 EUDAMEDOKM 862 EUDAMEDOKM 862 555 EUDAMEDOKM 862 000 EUDAMEDOKM 862 333 EUDAMEDOKM 862 999 EUDAMEDOKM 801 222 EUDAMEDOKM 862 111 EUDAMEDOKM 801 444 EUDAMEDOKM 801 999 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680992312071 EUDAMED08680992311470 EUDAMED08680992311814 EUDAMED08680992311791 EUDAMED08680992311784 EUDAMED08680992311890 EUDAMED08680992311487 EUDAMED08680992311777 EUDAMED08680992311500 EUDAMED08680992311432 EUDAMED08680992311913 EUDAMED
- Basic UDI-DI
- B-08680992312071 EUDAMEDB-08680992311470 EUDAMEDB-08680992311814 EUDAMEDB-08680992311791 EUDAMEDB-08680992311784 EUDAMEDB-08680992311890 EUDAMEDB-08680992311487 EUDAMEDB-08680992311777 EUDAMEDB-08680992311500 EUDAMEDB-08680992311432 EUDAMEDB-08680992311913 EUDAMED
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infant Incubator by Okuman Medikal Sistemler Anonim Sirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08680992312071 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (11)
- EUDAMED df9026a1-90cf-4dc5-aa08-301d7252c5ad 61 fields · synced Oct 8, 2026
- EUDAMED 3e7e0ebb-a62b-4ef4-b9a1-ac3ab285b2af 61 fields · synced May 16, 2026
- EUDAMED 95bec7eb-3fd2-4d19-9b7e-cd4c32f9919e 61 fields · synced May 17, 2026
- EUDAMED c5757555-5544-4e31-a601-1806988b62ad 61 fields · synced May 17, 2026
- EUDAMED 1ecb2ea1-6899-4fd9-b011-605516cb6ab2 61 fields · synced May 17, 2026
- EUDAMED 8ec7e03f-a2a3-4e59-a793-a1ba30831dad 61 fields · synced May 17, 2026
- EUDAMED 5eddc3b5-bd8e-4aef-b28d-c767a335bdcf 61 fields · synced May 18, 2026
- EUDAMED c2a94805-8a2d-46e8-89cd-890a7981b105 61 fields · synced May 18, 2026
- EUDAMED 0587daae-0e0f-4f17-b7e0-ec6ea93e402a 61 fields · synced May 19, 2026
- EUDAMED 07b6a897-d623-4c92-bce4-cc9e7e5165d9 61 fields · synced May 19, 2026
- EUDAMED c46a492b-3015-4a5f-8cac-87353013e2dd 61 fields · synced May 19, 2026